Senior Quality Compliance Manager
The Senior Quality & Compliance Manager is a position within Clinical Quality Control and Compliance (CQCC) responsible for assisting the CQCC Director to provide therapeutically aligned compliance support to study teams focusing on adherence to procedural/regulatory requirements. This role will take a leadership role in applying clinical compliance principles and methodology to CSL Clinical Development Therapeutic Area teams and will support the CQCC Director by driving clinical compliance-related activities including clinical risk management and ongoing inspection readiness during the conduct of clinical studies. This position will be seen as the CSL Subject Matter Expert in that regard, for which credibility and gravitas will play a key role in leading and implementing compliance principles and methodologies across Clinical Development.
RESPONSIBILITIES :
1. Provide compliance advice to study teams to ensure that clinical studies are carried out according to the study protocol, SOPs, ICH GCP Guidelines and applicable local regulatory requirements and will provide tactical insights into regulatory compliance strategies, risk evaluation, ongoing operational compliance advice.
2. Provide expert compliance risk support to assigned study programs including maintenance of risk-based Quality Management Plans to ensure adherence with procedural / regulatory requirements and driving inspection readiness
3. Manage ongoing inspection readiness activities for assigned programs and collaborate with Clinical QA to prepare internal and external staff. Support Global Clinical QA during the regulatory inspection process to provide expertise regarding the Clinical Development quality management system
4. Liaise with the Study File Management group by providing expert compliance advice to that group and monitoring the quality, completeness, timeliness and metrics of the eTMF and other study documentation management systems
5. Utilize in-depth business/regulatory knowledge to provide advice and, as necessary, assist in the quality control (QC) consistency checks of critical clinical documents to ensure compliance with internal policies/procedures, templates and formats required for regulatory filing and optimal clinical program/trial delivery
6. Work with study execution teams to investigate individual Corrective and Preventative Actions (CAPAs) to ensure issues/deviations are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed in a timely manner
7. Support the CQCC Director in reporting metrics, identifying trends and, where deemed to be necessary, evaluating the effectiveness of completed CAPAs to drive continuous improvement
8. Support the development of procedural documents (SOPs) to ensure regulatory compliance and consistency across Clinical Development.
9..Represent CQCC in collaborations with the Clinical Trials Process Improvement & Innovation group to drive continuous improvement initiatives identified through CAPAs, internal compliance monitoring and industry best practices/trends
10. Utilize and maintain strong customer relationships with non-Clinical Development functions whose activities overlap, influence or affect compliance.
Education :
Degree (BSc/MSc/Diploma) in scientific/medical/pharmaceutical discipline is essential, preferably combined with relevant clinical trial experience.
Requirements:
Experience :
•Extensive understanding of the clinical research and drug development lifecycle
•5-10 years of professional work experience in a Clinical Development/Research environment
•Experience in a supervisory role is desirable.
•Thorough knowledge of ICH GCP, FDA GCP regulations and EU clinical trial regulations
Travel Requirements :
•Minimal domestic and international travel required on an ad hoc basis
Worker Type:
Employee
Worker Sub Type:
Regular
